RESOLUTION OF THE CABINET OF MINISTERS OF UKRAINE

of October 3, 2018 No. 808

About approval of Licensed conditions of implementation of economic activity on production of veterinary medicines

According to Item 7, to paragraph one of part two of article 9 of the Law of Ukraine "About licensing of types of economic activity" the Cabinet of Ministers of Ukraine decides 33 parts one of Article:

1. Approve Licensed conditions of implementation of economic activity on production of veterinary medicines which are applied.

2. This resolution becomes effective in two months from the date of its publication.

Approved by the Resolution of the Cabinet of Ministers of Ukraine of October 3, 2018 No. 808

Licensed conditions of implementation of economic activity on production of veterinary medicines

General part

1. These Licensed conditions are developed according to the Law of Ukraine "About licensing of types of economic activity" and determine the list of the requirements obligatory for accomplishment by the licensee, and the exhaustive list of the documents enclosed to the application for receipt of the license for implementation of economic activity on production of veterinary medicines (further - the statement for receipt of the license).

2. Action of these Licensed conditions extends to the subjects of managing registered in the procedure established by the legislation as legal entities irrespective of their form of business and pattern of ownership which perform or intend to perform economic activity on production of veterinary medicines and on physical persons - entrepreneurs who perform or have intention to perform such activities (further - the subject of managing).

The licensee shall fulfill requirements of these Licensed conditions, and the license applicant on implementation of economic activity on production of veterinary medicines (further - the license) for its obtaining - to correspond to these Licensed conditions.

3. The terms used in these Licensed conditions have the following value:

producer of veterinary medicines - the subject of managing, irrespective of legal form and pattern of ownership which performs at least one of production phases of veterinary medicines, substances or their combinations, including packaging or packing;

production of veterinary medicines is the activities connected with serial release of veterinary medicines which include everything or at least one of transactions of engineering procedure, quality control, issue by the authorized person of permission to release (realization) of series of veterinary medicines;

production site - lanka (structural division) in production structure of the company for production of veterinary medicines combining group of the workplaces organized on subject, technology or subject technology to the principle of specialization in which the same technology works on production of veterinary medicines (production lines, rooms, zones) are performed;

the file of the site of the producer of veterinary medicines - the document which is prepared by producer of veterinary medicines and contains special information on the politician and activities of quality management on the site of production and/or control during transactions on production of the veterinary medicines performed on production and also about any closely interconnected works on the neighboring and adjacent sites of production. If on this site only part of technology transactions is performed, then in the file of the site of the producer of veterinary medicines only they shall be described (for example, the analysis, packaging and so forth);

the zone - part of the room, the square which is used for separate stage of engineering procedure and has clear visual boundary;

cross contamination - pollution of raw materials or products other raw materials or products;

air lock - the limited space with two or several doors between two or several rooms, for example, different classes of purity intended for control of flow of air between these rooms when it is necessary to enter them. Air locks intend and used for movement, both people, and things;

the authorized person of the producer of veterinary medicines (further - the authorized person) - person who has the higher education on specialties "Pharmacy, Industrial Pharmacy", "Veterinary Medicine", "Chemical Technologies and Engineering", "Biotechnologies and Bioengineering", "Biomedical Engineering", "Chemistry", "Biology" and length of service in at least two years in the field of production, quality control or creation of veterinary medicines, is responsible for functioning of the pharmaceutical quality system during production of each series of veterinary medicine and provision of permission to release (realization) of veterinary medicines.

Other terms are used in the value given in the Laws of Ukraine "About veterinary medicine" and "About licensing of types of economic activity".

4. Implementation of economic activity on production of veterinary medicines is performed through production site, the warehouse area (rooms for storage, warehouse), quality control zone, zone of issue of permission to release of veterinary medicines.

5. Requirements of these Licensed conditions extend to places of implementation of economic activity of the licensee which are specified in the documents enclosed to the application for receipt of the license (taking into account the changes made to them provided by the licensee to body of licensing).

6. For receipt of the license for implementation of economic activity on production of veterinary medicines the subject of managing submits the application for receipt of the license to body of licensing (appendix 1) by the method determined by part one of article 10 of the Law of Ukraine "About licensing of types of economic activity".

All places of implementation of type of economic activity which is licensed are specified in the statement.

If documents are filed purposely, the license applicant shows the document proving his identity.

In case of submission of documents by the representative of the license applicant the original document (verified copy) certifying its powers is in addition shown.

7. The following documents are enclosed to the application for receipt of the license:

1) supporting documents concerning each place of implementation of economic activity on production of veterinary medicines:

data of the subject of managing on availability of material and technical resources and availability of specialists which have educational and qualification level, necessary for implementation of economic activity on production of veterinary medicines (appendix 2);

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